Gufic Biosciences gets DCGI nod for Thymosin Alpha-1 in Covid-19
Gufic Biosciences has secured approval from the Drugs Controller General of India (DCGI) for Thymosin Alpha-1 (Immunocin α) as an add-on therapy for the treatment of moderate-to-severe Covid-19 patients needing ventilator support (NIV and mechanical ventilation).
Immunocin α, which is an immuno-modulator drug, considerably cut down the risk of death in phase 3 clinical trial in adults having moderate-to-severe Covid-19.
The drug is an endogenous polypeptide hormone produced by thymic epithelial cells. As an immunomodulatory therapy, Thymosin α 1 has been studied in various diseases involving immune dysfunction such as sepsis, hepatitis viral infection, and cystic fibrosis.
Thymosin α 1 is said to boost T cell numbers by promoting the development and proliferation of T cells, improving their function and stopping and correcting lymphopaenia.
Dr. Adarsh Shetty — General Manager – Medical Affairs of Gufic Biosciences said: “Looking at the convincing results, we are optimistic that Immunocin α can become an important drug amongst the global efforts to fight the COVID-19 pandemic and will add to Gufic’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most. Gufic has been relentlessly committed to saving and improving lives.
“We will continue to work with regulatory agencies on our applications and do everything we can to bring novel molecules to patients as quickly as possible.”